NDC Code(s) : 0316-2071-10, 0316-2071-30, 0316-2071-40, 0316-2071-50, 0316-2071-60, 0316-2071-45
Packager : Crown Laboratories

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blue Lizard Active SunscreenOctocrylene and Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2071
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE41.8 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE104.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CHLORPHENESIN(UNII: I670DAL4SZ)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
YELLOW WAX(UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
ETHYLHEXYL STEARATE(UNII: EG3PA2K3K5)
DIMETHICONE(UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)(UNII: AG75W62QYU)
WATER(UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)(UNII: 25LXE464L2)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
METHYL GLUCOSE DIOLEATE(UNII: FA9KFJ4Z6P)
PEG-7 HYDROGENATED CASTOR OIL(UNII: WE09129TH5)
EDETATE DISODIUM(UNII: 7FLD91C86K)
OCTYLDODECYL NEOPENTANOATE(UNII: X8725R883T)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
PROPANEDIOL(UNII: 5965N8W85T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0316-2071-105 mL in 1 PACKET Type 0: Not a Combination Product01/02/2019
2NDC:0316-2071-3089 mL in 1 TUBE Type 0: Not a Combination Product01/02/2019
3NDC:0316-2071-401 in 1 CARTON 01/02/2019
3148 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/02/2019
4NDC:0316-2071-50259 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/02/2019
5NDC:0316-2071-603785 mL in 1 JUG Type 0: Not a Combination Product01/02/2019
6NDC:0316-2071-45148 mL in 1 TUBE Type 0: Not a Combination Product01/02/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 01/02/2019

LABELER - Crown Laboratories(079035945)

Establishment
Name Address ID/FEI Business Operations
Crown Laboratories 079035945 manufacture(0316-2071)

PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

ACTIVE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Bottle TECHNOLOGY

BOTTLE CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

8.75fl oz (259ml)

P11490.02

p1149002